PresbylarynxNCT03702322
Improving Voice Production for Adults With Age-related Dysphonia
A study testing Voice therapy: respiratory, Voice therapy: glottal closure and Voice therapy: loud in people with Presbylarynx and Age-Related Dysphonia, run by University of Arizona at 2 sites in United States.
Trial summary
The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Presbylarynx, Age-Related Dysphonia
- What is being tested?
- Voice therapy: respiratory, Voice therapy: glottal closure and Voice therapy: loud
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2019to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults in age range who volunteer
- Can understand and complete directions presented in English
- People with voice disorder associated with advancing age will be included, including bowing, incomplete closure, mild edema, erythema, signs of laryngopharyngeal reflux.
Who cannot join
- Laryngeal differences not related to aging (e.g., vocal fold paralysis, moderate-severe edema, lesions, leukoplakia, dysplasia, Parkinson disease)
- Known history of stroke, brain injury, or other neurological disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Scottsdale, Arizona, 85259
University of Arizona
Tucson, Arizona, 85721
About this study
The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. The central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.
- Conditions
- Presbylarynx, Age-Related Dysphonia
- Being tested
- Voice therapy: respiratory, Voice therapy: glottal closure, Voice therapy: loud, Voice therapy: Semiocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Voice therapy: respiratoryBehavioural
Abdominal voice onset
Voice therapy: glottal closureBehavioural
Pulling/pushing task
Voice therapy: loudBehavioural
Assertive task
Voice therapy: SemiocclusionBehavioural
Semi-occluded vocal tract
| Study group | Role | What they receive |
|---|---|---|
| Participants | Other | All participants will undergo each treatment. Receives: Behavioral: Voice therapy: respiratory; Behavioral: Voice therapy: glottal closure; Behavioral: Voice therapy: loud; Behavioral: Voice therapy: Semiocclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative glottal gap from laryngeal high-speed videoendoscopy
Measured: End of year 3
Perceived voice quality
Participants will score the construct of "overall voice quality" using a technique called "sort and rate" in which listeners move icons representing each sound along a line. They align the icons so that best voices are on one side and worst voices are on the other. The distance between the icons represents how much better or worse one sound is than the other. There are no units to the scale. Rankings from all listeners are combined using the statistical technique of multidimensional scaling. The result is a ranked value for each sound file (i.e., voice production) that shows how different they are. There is no highest or lowest value.
Measured: End of year 3
Acoustic measure of voice quality (Cepstral Peak Prominence)
Measured: End of year 3
Secondary outcomes (4)
Open quotient from laryngeal high-speed videoendoscopy
Measured: End of year 3
Speed index from laryngeal high-speed videoendoscopy
Measured: End of year 3
Maximum area declination ratefrom laryngeal high-speed videoendoscopy
Measured: End of year 3
Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy
Measured: End of year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2018
- Study start1 Apr 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PresbylarynxStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive every intervention in randomized order
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Robin A Samlan, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03702322
- Sponsor's protocol ID
- R21DC016356
- Status last verified
- Oct 2025
- First submitted
- 17 Sep 2018
- Last updated
- 10 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Voice Production for Adults With Age-related Dysphonia
- ClinicalTrials.gov ID
- NCT03702322
- Acronym / sponsor ID
- R21DC016356
- Conditions
- Presbylarynx, Age-Related Dysphonia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives for this research are to determine the mechanisms by which specific therapy tasks improve voice in age-related dysphonia, and the conditions that limit the extent of improvement. The central hypothesis is that targeted therapy tasks will improve voice, and that severity will determine the extent of improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive every intervention in randomized order
| Arm | Type | Receives |
|---|---|---|
| Participants | Other | Behavioral: Voice therapy: respiratory, Behavioral: Voice therapy: glottal closure, Behavioral: Voice therapy: loud, Behavioral: Voice therapy: SemiocclusionAll participants will undergo each treatment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Adults in age range who volunteer
- Can understand and complete directions presented in English
- People with voice disorder associated with advancing age will be included, including bowing, incomplete closure, mild edema, erythema, signs of laryngopharyngeal reflux.
Key exclusion criteria (2 listed)
- Laryngeal differences not related to aging (e.g., vocal fold paralysis, moderate-severe edema, lesions, leukoplakia, dysplasia, Parkinson disease)
- Known history of stroke, brain injury, or other neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Voice therapy: respiratoryAbdominal voice onset | Behavioural | Participants |
| Voice therapy: glottal closurePulling/pushing task | Behavioural | Participants |
| Voice therapy: loudAssertive task | Behavioural | Participants |
| Voice therapy: SemiocclusionSemi-occluded vocal tract | Behavioural | Participants |
Primary outcome
Relative glottal gap from laryngeal high-speed videoendoscopy
Time frame: End of year 3
Perceived voice quality
Time frame: End of year 3
Participants will score the construct of "overall voice quality" using a technique called "sort and rate" in which listeners move icons representing each sound along a line. They align the icons so that best voices are on one side and worst voices are on the other. The distance between the icons represents how much better or worse one sound is than the other. There are no units to the scale. Rankings from all listeners are combined using the statistical technique of multidimensional scaling. The result is a ranked value for each sound file (i.e., voice production) that shows how different they are. There is no highest or lowest value.
Acoustic measure of voice quality (Cepstral Peak Prominence)
Time frame: End of year 3
4 secondary outcomes
Open quotient from laryngeal high-speed videoendoscopy
Time frame: End of year 3
Speed index from laryngeal high-speed videoendoscopy
Time frame: End of year 3
Maximum area declination ratefrom laryngeal high-speed videoendoscopy
Time frame: End of year 3
Fundamental frequency standard deviation from laryngeal high-speed videoendoscopy
Time frame: End of year 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin A Samlan, Ph.D. principal investigator
University of Arizona
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Voice therapy: respiratory, Voice therapy: glottal closure and Voice therapy: loud in people with Presbylarynx and Age-Related Dysphonia, run by University of Arizona at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative glottal gap from laryngeal high-speed videoendoscopy (time frame: End of year 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2025.